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Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients

ConditionsCMVLung Transplant Recipient
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

The primary objective of the CLEAR-CMV trial is to evaluate the efficacy of letermovir therapy plus standard of care (SOC) antiviral compared to SOC plus placebo in achieving clearance of CMV viremia by week 3 in lung transplant recipients with active CMV infection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Recipient of a lung transplant.

Has confirmed CMV viremia with a viral load ≥ 1000 IU/mL and will receive or has just started SOC antiviral treatment in the past 72h as per the decision of the treating physician.

Disqualifiers

Renal failure with Creatinine clearance <15 mL/min or requiring dialysis

Severe hepatic impairment (Child-Pugh Class C)

Participating in another interventional clinical trial

Combined transplant (e.g heart-lung, lung-liver)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Letermovir

    Drug

    Letermovir (480mg) will be given orally as a loading dose every 12 hours for the first 24 hours, then one tablet per day for a total treatment duration of 21 days. Letermovir treatment will be started within 72 hours of starting SOC antiviral treatment as per the decision of the treating physician.

  • Placebo

    Drug

    Placebo will be dosed the same as letermovir: one tablet every 12 hours for the first 24 hours, then one tablet per day for total treatment duration of 21 days.

  • Valganciclovir/Ganciclovir

    Drug

    Ganciclovir or its oral prodrug, valganciclovir will be administered as the standard of care antiviral therapy. Its duration will be at the discretion of the treatment physician but is typically given until clearance of viremia. The clinical definition of viral clearance is one negative viral load or two viral loads one week apart that are \<200 IU/mL

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: SOC antiviral plus placeboPlacebo comparator 2 interventions
Group B: SOC antiviral plus letermovir active drugExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Proportion of patients achieving clearance of CMV viremia by week 3, as measured by quantitative PCR.

Viral clearance is described by a plasma CMV viral load \< 200 IU/mL, the UHN clinically used threshold

Time frame
From time of enrollment until 3 weeks after enrolment

Secondary outcomes

1

Proportion of patients achieving an undetectable viral load

The limit of detection for plasma CMV viral load is 35 IU/mL

Time frame
At week 3 and by month 6 after enrolment
2

Proportion of patients achieving CMV viral load <137 IU/mL (lower limit of quantification of the assay)

Lower limit of viral quantitation

Time frame
At week 3 from enrolment and at 6 months
3

Time to clearance of CMV viremia

Clearance of CMV viremia is defined as plasma CMV viral load \< 200 IU/mL as measured by quantitative PCR

Time frame
From enrolment until clearance of CMV viremia, up to 6 months after enrolment
4

Time to resolution of symptoms if present

Time frame
From enrolment until clearance of symptoms, up to 6 months after enrolment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov
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